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No grant was received then we stopped the recruitment
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The investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to GnRH analogs.
Uterine leiomyoma is the most prevalent benign gynecologic tumor in women. Standard treatment is surgical (hysterectomy or myomectomy), and depends of many variables. If these tumors are large, preoperative assessment with clinical treatment may be useful in order to decrease its volume, improve hematologic patterns and modify surgical approach (vaginal or abdominal). It is well know that GnRH analogs can cause these goals; however, aromatase inhibitors are new promising drugs which are being used for reducing uterine leiomyoma's volume and few observational studies have shown this fact. The investigators are aiming to compare both treatments in a randomized controlled trial and see if it both treatments are similar or not in decreasing uterine leiomyoma's volume, influencing operative time, blood loss during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AROMATASE INHIBITOR | Experimental | this would be compared before and after VAGINAL HYSTERECTOMY |
|
| GNRH ANALOG | Active Comparator | this would be compared before and after VAGINAL HYSTERECTOMY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAGINAL HYSTERECTOMY | Procedure | GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Intra-operative time | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine Leiomyoma Volume | Volume measured by ultrasound | 3 Months After Treatment, During Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19135657 | Result | Parsanezhad ME, Azmoon M, Alborzi S, Rajaeefard A, Zarei A, Kazerooni T, Frank V, Schmidt EH. A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. Fertil Steril. 2010 Jan;93(1):192-8. doi: 10.1016/j.fertnstert.2008.09.064. Epub 2009 Jan 9. |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007045 | Hysterectomy, Vaginal |
| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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We woudl be comparing aromatase inhibitors versus GnRH analogs
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| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |